<PAGE>
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
______________________________
FORM 10-Q
(Mark One)
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the quarterly period ended June 30, 2000
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM
_____________ to _____________
Commission File Number: 0-27605
______________________________
VASCULAR SOLUTIONS, INC.
(Exact name of registrant as specified in its charter)
MINNESOTA 41-1859679
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
2495 Xenium Lane North
Minneapolis, Minnesota 55441
(Address of principal executive offices) (Zip Code)
(763) 656-4300
(Registrant's telephone number, including area code)
______________________________
Indicate by check mark whether the registrant: (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days.
YES [_] NO [X]
The Registrant had 12,562,528 shares of Common Stock, $0.01 par value per share,
outstanding as of August 1, 2000.
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VASCULAR SOLUTIONS, INC.
TABLE OF CONTENTS
<TABLE>
<CAPTION>
Page
----
<S> <C>
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements (Unaudited)
Balance Sheets as of June 30, 2000 and December 31, 1999 2
Statements of Operations for the three months ended June 30, 2000 and 1999
and for the six months ended June 30, 2000 and 1999 3
Statements of Cash Flows for the three months ended June 30, 2000 and 1999
and for the six months ended June 30, 2000 and 1999 4
Notes to Unaudited Financial Statements 5
Item 2. Management's Discussion and Analysis of Financial Condition and
Results of Operations 7
Item 3. Quantitative and Qualitative Disclosure About Market Risks 19
PART II. OTHER INFORMATION
Item 1. Legal Proceedings 19
Item 2. Changes in Securities and Use of Proceeds 20
Item 3. Defaults upon Senior Securities 21
Item 4. Submission of Matters to a Vote of Security Holders 21
Item 5. Other Information 21
Item 6. Exhibits and Reports on Form 8-K 21
</TABLE>
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VASCULAR SOLUTIONS, INC.
BALANCE SHEETS
<TABLE>
<CAPTION>
June 30, December 31,
2000 1999
------------ ------------
(unaudited) (Note)
<S> <C> <C>
Assets
Current assets:
Cash and cash equivalents..................................... $ 5,088,522 $ 10,529,191
Accounts receivable, net of allowance of
$20,000 at June 30, 2000.................................... 753,550 374,978
Inventories................................................... 1,143,897 612,569
Prepaid expenses.............................................. 324,638 93,177
------------ ------------
Total current assets....................................... 7,310,607 11,609,915
Property and equipment, net..................................... 871,521 684,952
------------ ------------
Total assets............................................... $ 8,182,128 $ 12,294,867
============ ============
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable.............................................. $ 1,127,558 $ 1,019,715
Accrued expenses.............................................. 541,330 102,954
------------ ------------
Total current liabilities.................................. 1,668,888 1,122,669
Commitments and contingencies
Shareholders' equity:
Series A preferred stock, $.01 par value;
2,000,000 shares authorized; 2,000,000
shares issued and outstanding............................... 20,000 20,000
Series B preferred stock, $.01 par value;
1,777,777 shares authorized; 1,777,777
shares issued and outstanding............................... 17,778 17,778
Common stock, $.01 par value;
36,222,223 and 16,222,223 shares authorized in 2000
and 1999, respectively; 5,278,091 and 5,250,291 shares
issued and outstanding in 2000 and 1999, respectively...... 52,781 52,503
Additional paid-in capital...................................... 25,917,781 25,828,309
Deferred compensation........................................... (89,540) (90,931)
Accumulated deficit............................................. (19,405,560) (14,655,461)
------------ ------------
Total shareholders' equity.................................... 6,513,240 11,172,198
------------ ------------
Total liabilities and shareholders' equity................. $ 8,182,128 $ 12,294,867
============ ============
</TABLE>
See accompanying notes.
Note: The balance sheet at December 31, 1999 has been derived from the audited
financial statements at that date but does not include all of the information
and footnotes required by generally accepted accounting principles for complete
financial statements.
2
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VASCULAR SOLUTIONS, INC.
STATEMENTS OF OPERATIONS
<TABLE>
<CAPTION>
Three Months Ended Six Months Ended
June 30, June 30,
2000 1999 2000 1999
----------- ----------- ----------- -----------
(unaudited) (unaudited)
<S> <C> <C> <C> <C>
Net sales.................................... $ 708,250 $ 307,500 $ 1,350,795 $ 514,500
Cost of goods sold........................... 353,706 256,393 702,557 442,337
----------- ----------- ----------- -----------
Gross profit................................. 354,544 51,107 648,238 72,163
Operating expenses:
Research and development................... 854,763 933,707 1,546,486 1,646,978
Clinical and regulatory.................... 336,703 302,707 526,607 882,303
Sales and marketing........................ 1,409,597 499,364 2,310,912 849,429
General and administrative................. 665,107 214,383 1,228,679 409,460
----------- ----------- ----------- -----------
Total operating expenses................ 3,266,170 1,950,161 5,612,684 3,788,170
----------- ----------- ----------- -----------
Operating loss.......................... (2,911,626) (1,899,054) (4,964,446) (3,716,007)
Interest income.............................. 92,648 80,162 214,347 183,036
----------- ----------- ----------- -----------
Net loss................................ $(2,818,978) $(1,818,892) $(4,750,099) $(3,532,971)
=========== =========== =========== ===========
Basic and diluted net loss per share......... $ (.53) $ (.49) $ (.90) $ (.95)
=========== =========== =========== ===========
Shares used in computing basic and
diluted net loss per share................. 5,271,456 3,716,967 5,263,171 3,708,568
=========== =========== =========== ===========
</TABLE>
See accompanying notes.
3
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VASCULAR SOLUTIONS, INC.
STATEMENTS OF CASH FLOWS
<TABLE>
<CAPTION>
Three Months Ended Six Months Ended
June 30, June 30,
2000 1999 2000 1999
----------- ----------- ----------- -----------
(unaudited) (unaudited)
<S> <C> <C> <C> <C>
Operating activities
Net loss....................................... $(2,818,978) $(1,818,892) $(4,750,099) $(3,532,971)
Adjustments to reconcile net loss to
net cash used in operating activities:
Depreciation and amortization............... 83,336 59,793 164,060 113,471
Value of options granted for services....... -- 3,340 -- 13,360
Value of warrant granted related
to supply agreement........................ -- 257,000 -- 257,000
Deferred compensation expense............... 17,829 13,070 36,141 13,070
Changes in operating assets and
liabilities:
Accounts receivable........................ (151,481) (91,000) (378,572) (158,000)
Inventories................................ (289,595) (42,158) (531,328) (156,735)
Prepaid expenses........................... (228,715) 28,662 (231,461) (11,656)
Accounts payable........................... 218,442 23,664 107,843 (8,983)
Accrued expenses...................... 352,343 (70,473) 438,376 (107,792)
----------- ----------- ----------- -----------
Net cash used in operating activities.... (2,816,819) (1,636,994) (5,145,040) (3,579,236)
Investing activities
Purchase of property and equipment............. (192,132) (87,942) (350,629) (150,280)
----------- ----------- ----------- -----------
Net cash used in investing activities.... (192,132) (87,942) (350,629) (150,280)
Financing activities
Proceeds from exercise of stock options...... 32,800 3,031,350 55,000 3,033,870
----------- ----------- ----------- -----------
Net cash provided by financing
Activities............................ 32,800 3,031,350 55,000 3,033,870
----------- ----------- ----------- -----------
Increase (decrease) in cash
and cash equivalents.................... (2,976,151) 1,306,414 (5,440,669) (695,646)
Cash and cash equivalents at beginning of
period....................................... 8,064,673 7,894,993 10,529,191 9,897,053
----------- ----------- ----------- -----------
Cash and cash equivalents at end of period...... $ 5,088,522 $ 9,201,407 $ 5,088,522 $ 9,201,407
=========== =========== =========== ===========
</TABLE>
See accompanying notes.
4
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VASCULAR SOLUTIONS, INC.
Notes to Unaudited Financial Statements
(1) Basis of Presentation
The accompanying unaudited financial statements of Vascular Solutions, Inc.
(the "Company") have been prepared in accordance with generally accepted
accounting principles for interim financial information and with the
instructions to Form 10-Q and Regulation S-X. Accordingly, they do not
include all of the information and footnotes required by generally accepted
accounting principles for complete financial statements. In the opinion of
management, all normal, recurring adjustments considered necessary for a
fair presentation have been included. The financial statements should be
read in conjunction with the audited financial statements for the year
ended December 31, 1999 included in the Registration Statement on Form S-1
of Vascular Solutions, Inc., as amended, filed with the Securities and
Exchange Commission (File No. 333-84089). Interim results of operations are
not necessarily indicative of the results to be expected for the full year
or any other interim periods.
(2) Computation of Net Loss per Share
In accordance with Statement of Financial Accounting Standards No. 128,
Earnings Per Share, (SFAS 128), basic net loss per share for the three
months and six months ended June 30, 2000 and 1999 is computed by dividing
net loss by the weighted average common shares outstanding during the
periods presented. Diluted net loss per share is computed by dividing net
loss by the weighted average common and dilutive potential common shares
outstanding computed in accordance with the treasury stock method. For all
periods presented, diluted loss per share is the same as basic loss per
share, because the effect of outstanding options, warrants and convertible
preferred stock is antidilutive.
(3) Revenue Recognition
The Company generally sells its products to international distributors
which subsequently resell the products to hospitals and clinics. The
Company has agreements with each of its distributors which provide that
title and risk of loss pass to the distributor upon shipment of the
products to the distributor. The Company warrants that its products are
free from manufacturing defects at the time of shipment to the distributor.
Revenue is recognized upon shipment of products to distributors following
the receipt and acceptance of a distributor's purchase order. Allowances
are provided for estimated warranty costs at the time of shipment. To date,
warranty costs have been insignificant.
5
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VASCULAR SOLUTIONS, INC.
Notes to Unaudited Financial Statements-Continued
(4) Inventories
Inventories are stated at the lower of cost (first-in, first-out method) or
market and are comprised of the following at:
<TABLE>
<CAPTION>
June 30, December 31,
2000 1999
---- ----
(unaudited)
<S> <C> <C>
Raw materials............................ $ 702,308 $451,955
Work-in process.......................... 385,916 103,285
Finished goods........................... 55,673 57,329
---------- --------
$1,143,897 $612,569
========== ========
</TABLE>
(5) Concentrations of Credit and Other Risks
Financial instruments that potentially subject the Company to
concentrations of credit risk consist primarily of cash and cash
equivalents and accounts receivables. The Company maintains its accounts
for cash and cash equivalents principally at one major bank in the United
States. The Company has a formal written investment policy that restricts
the placement of investments to issuers evaluated as creditworthy. The
Company has not experienced any losses on its deposits of its cash and cash
equivalents.
With respect to accounts receivable, the Company performs credit
evaluations of its customers and does not require collateral. Three
customers accounted for 78% of total accounts receivable as of June 30,
2000. Two customers accounted for 51% of total accounts receivable as of
December 31, 1999. There have been no material losses on customer
receivables.
The Company operates in a single industry segment and sells its product to
distributors who, in turn, sell to medical clinics. The Company sells its
product in foreign countries through independent distributors denominated
in United States dollars. Loss, termination or ineffectiveness of
distributors to effectively promote the Company's product would have a
material adverse effect on the Company's financial condition and results of
operations.
Sales to significant customers as a percentage of total net sales are as
follows for the six months ended June 30, 2000 and 1999:
<TABLE>
<CAPTION>
2000 1999
---- ----
<S> <C> <C>
German distributor............................... 30.2% 24.9%
Norwegian distributor............................ 25.8% 22.3%
Italian distributor.............................. 16.6% 16.1%
Austrian distributor............................. 9.3% 14.6%
</TABLE>
6
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(6) Initial Public Offering
On July 25, 2000, the Company completed the initial public offering of its
common stock. Upon the closing of the initial public offering, the Company
issued 3,500,000 shares of its common stock at an offering price of $12.00
per share and all of the Company's Series A and Series B preferred stock
automatically converted into 3,777,777 shares of common stock. The
underwriters have a 30-day option to purchase an additional 525,000 shares
of common stock at $12.00 per share expiring on August 19, 2000. Cash
proceeds from the sale of the 3,500,000 shares of common stock, net of
underwriters' discount and offering expenses, totaled approximately $38.7
million. Upon closing of the Company's initial public offering, the
authorized capital stock of the Company consisted of 40,000,000 shares of
common stock, par value $.01 per share, with no shares of preferred stock
outstanding or designated.
Item 2. Management's Discussion and Analysis of Financial Condition and
Results of Operations
This Quarterly Report on Form 10-Q contains, in addition to historical
information, forward-looking statements which involve risks and uncertainties.
Our actual results could differ significantly from the results discussed in such
forward-looking statements. See "Factors Affecting Future Operating Results"
below.
Overview
Since commencing operations in February 1997, we have been engaged in the
design, development, clinical testing and, more recently, the manufacture and
sale in international markets of the Vascular Solutions Duett/TM/ sealing
device. Our Duett sealing device is designed to seal the entire puncture site
following catheterization procedures such as angiography, angioplasty and
stenting. We have received regulatory approvals to market the Duett sealing
device in several international markets, principally in Europe. On June 22,
2000, we received approval from the United States Food and Drug Administration
or FDA of our premarket approval or PMA application for the sale of our Duett
sealing device in the United States. As a result, we very recently commenced
sales of our product in the United States with a direct sales force.
We have a limited history of operations and have experienced significant
operating losses since inception. As of June 30, 2000, we had an accumulated
deficit of $19.4 million. We commenced international sales in February 1998. To
date, we have generated substantially all of our revenue from sales of the Duett
sealing device to international distributors who resell the device to hospitals.
Although we have experienced revenue growth in recent periods, this growth may
not be sustainable and, therefore, these recent periods should not be considered
indicative of future performance. We may never achieve significant revenues or
profitability, or if we achieve significant revenues they may not be sustained
in future periods.
Results of Operations
Three months ended June 30, 2000 compared to three months ended June 30, 1999
Net sales increased 130% to $708,250 for the three months ended June 30, 2000
from $307,500 for the three months ended June 30, 1999. This increase in net
sales was the result of increased shipments of the Duett sealing device to our
distributors for sale in Europe. Sales to our German, Norwegian, Italian
7
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and Austrian distributors accounted for approximately 35%, 26%, 16% and 8% of
net sales for the three months ended June 30, 2000.
Gross profit as a percentage of net sales increased to 50% for the three
months ended June 30, 2000 from 17% for the three months ended June 30, 1999.
This increase as a percentage of net sales resulted from a decrease in cost of
goods sold due to the conversion to the Duett Model 2000 for international sales
in the fourth quarter of 1999 and improved manufacturing processes. Cost of
goods sold consists primarily of direct material component costs, personnel
expenses and manufacturing equipment and overhead related to the production of
our Duett sealing device. The Duett Model 2000 incorporates minor modifications
to the procoagulant components and different vendors for certain components,
resulting in lower cost of goods compared to the original Duett Model 1000. The
approval we recently received from the FDA applies to the Duett Model 1000. We
will not be able to sell the Duett Model 2000 in the United States until we
receive approval of a PMA supplement. We do not expect to receive FDA approval
of a PMA supplement for the Duett Model 2000 prior to late-2001. We expect gross
profit as a percentage of net sales to continue to increase as we increase our
manufacturing volume, improve our manufacturing processes, and enter the United
States market.
Research and development expenses decreased 8% to $854,763 for the three
months ended June 30, 2000 from $933,707 for the three months ended June 30,
1999. This slight decrease was attributable to the increased absorption of
additional capacity by manufacturing and the transition of the Duett Model 2000
to production. We expect our research and development expenses to increase
through the remainder of 2000 as we hire additional development personnel,
continue work on product improvements and explore new product opportunities.
Clinical and regulatory expenses increased 11% to $336,703 for the three
months ended June 30, 2000 from $302,707 for the three months ended June 30,
1999. These expenses consist primarily of payments to clinics for participation
in clinical studies, company personnel related to clinical study administration
and payments to regulatory agencies as part of the product approval process. The
increase was primarily the result of costs associated with the 300-patient
multi-center FDA clinical study of the Duett Model 2000 which was commenced in
March 2000 and was completed in June 2000. We expect our clinical and
regulatory expenses to remain relatively constant during the remainder of 2000
compared to the quarter ended June 30, 2000.
Sales and marketing expenses increased 182% to $1,409,597 for the three months
ended June 30, 2000 from $499,364 for the three months ended June 30, 1999. This
increase was due primarily to additional personnel and travel for the
international distribution of our Duett sealing device. We currently anticipate
that sales and marketing expenses will increase for the foreseeable future as we
hire, train and deploy a direct sales force in the United States. These expenses
will be principally related to hiring additional sales and marketing personnel,
expanding marketing efforts and training new physicians.
General and administrative expenses increased 210% to $665,107 for the three
months ended June 30, 2000 from $214,383 for the three months ended June 30,
1999. This increase was primarily attributable to a substantial increase in
legal fees associated with litigation items (See "Legal Proceedings" in Item 1
of Part II of this Form 10-Q) and increase in personnel costs to support
increased operations. We anticipate that general and administrative expenses
will increase for the foreseeable future as we continue to incur substantial
litigation expenses related to patent infringement claims and add personnel and
infrastructure.
Interest income increased to $92,648 for the three months ended June 30, 2000
from $80,162 for the three months ended June 30, 1999 primarily as a result of
higher cash balances resulting from higher money market interest rates and cash
balances.
8
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Six months ended June 30, 2000 compared to six months ended June 30, 1999
Net sales increased 163% to $1,350,795 for the six months ended June 30, 2000
from $514,500 for the six months ended June 30, 1999. The increase in net sales
was the result of increased shipments of our Duett sealing device to existing
independent international distributors and shipments to new independent
international distributors covering other territories. International sales of
our Duett sealing device commenced in February 1998. Sales to our German,
Norwegian, Italian and Austrian distributors accounted for approximately 30%,
26%, 17% and 9% of net sales for the six months ended June 30, 2000.
Gross profit as a percentage of net sales increased to 48% for the six months
ended June 30, 2000 from 14% for the six months ended June 30, 1999. This
increase as a percentage of net sales resulted from a decrease in cost of goods
sold due to the conversion to the Duett Model 2000 for international sales in
the fourth quarter of 1999 and improved manufacturing processes.
Research and development expenses decreased 6% to $1,546,486 for the six
months ended June 30, 2000 from $1,646,978 for the six months ended June 30,
1999. This slight decrease was attributable to the increased absorption of
additional capacity by manufacturing and the transition of the Duett Model 2000
to production.
Clinical and regulatory expenses decreased 40% to $526,607 for the six months
ended June 30, 2000 from $882,303 for the six months ended June 30, 1999. The
decrease was primarily the result of costs associated with the 695-patient
multi-center clinical study of our Duett sealing device which commenced in
August 1998 and was completed in March 1999. In addition to the payments to the
clinical centers for patient enrollment and data collection, we contracted with
a third party to perform data analysis and computation for the study. We also
contracted with a third party to perform a cost outcomes study of the patient
data from this multi-center study.
Sales and marketing expenses increased 172% to $2,310,912 for the six months
ended June 30, 2000 from $849,429 for the six months ended June 30, 1999. This
increase was due primarily to $891,400 in increased personnel costs and $353,700
associated with travel, marketing and physician training for the international
distribution of the Duett sealing device.
General and administrative expenses increased 200% to $1,228,679 for the six
months ended June 30, 2000 from $409,460 for the six months ended June 30, 1999.
This increase was primarily attributable to a substantial increase in legal fees
associated with litigation items and increase in personnel costs.
Interest income increased to $214,347 for six months ended June 30, 2000 from
$183,036 for the six months ended June 30, 1999 primarily as a result of higher
money market interest rates and cash and cash equivalents balances.
Income Taxes
We have not generated any pre-tax income to date and therefore have not paid
any federal income taxes since inception in December 1996. No provision or
benefit for federal and state income taxes has been recorded for net operating
losses incurred in any period since our inception.
As of June 30, 2000, we had approximately $17,085,000 of federal net operating
loss carryforwards available to offset future taxable income which begin to
expire in the year 2013. As of June 30, 2000, we also had federal and state
research and development tax credit carryforwards of approximately $339,000
9
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which begin to expire in the year 2013. Under the Tax Reform Act of 1986, the
amounts of and benefits from net operating loss carryforwards may be impaired or
limited in certain circumstances, including significant changes in ownership
interests. Future use of our existing net operating loss carryforwards may be
restricted due to changes in ownership or from future tax legislation.
We have established a valuation allowance against the entire amount of our
deferred tax asset because we have not been able to conclude that it is more
likely than not that we will be able to realize the deferred tax asset, due
primarily to our history of operating losses.
Liquidity and Capital Resources
We have financed all of our operations since inception through the issuance of
equity securities. Through June 30, 2000, we have sold common stock and
preferred stock generating aggregate net proceeds of $25.4 million. On July 25,
2000, we completed the initial public offering or our common stock. Upon the
closing of the initial public offering, we received cash proceeds, net of
underwriters' discount and offering expenses, of approximately $38.7 million.
At June 30, 2000, we had $5.1 million in cash and cash equivalents on-hand.
During the three months ended June 30, 2000, we used $2.8 million of cash and
cash equivalents in operating activities. The cash used in operating activities
was primarily used to fund our net loss for the period of $2.8 million and
increases in accounts receivable and inventories to support our increased
operations. For the six months ended June 30, 2000, we used $5.1 million of cash
in operating activities. This was primarily used to fund our net loss for the
period of $4.8 million and increases in accounts receivable and inventories.
Cash used in operating activities was partially offset by an increase of
$546,000 in accounts payable and accrued expenses. Our other use of cash in
each of these periods was investing activities to acquire manufacturing and
office equipment. Our equipment acquisitions totaled $192,000 during the three
months ended June 30, 2000 and $351,000 during the six months ended June 30,
2000.
We do not have any significant cash commitments related to supply agreements,
nor do we have any commitments for capital expenditures.
We currently anticipate that we will continue to experience significant growth
in our expenses for the foreseeable future and our expenses will be a material
use of our cash resources. We anticipate that our operating losses will continue
through at least December 31, 2000, because we plan to spend substantial amounts
hiring and training a direct United States sales force, funding sales and
marketing activities and creating and expanding research and development
initiatives. We believe that current cash balances along with cash generated
from the future sales of products will be sufficient to meet our operating and
capital requirements through at least the end of 2001. Our liquidity and capital
requirements beyond 2001 will depend on numerous factors, including the extent
to which our Duett sealing device gains market acceptance and competitive
developments.
Factors Affecting Future Operating Results
Certain information contained in this Quarterly Report on Form 10-Q contains
various "forward-looking statements" within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended. Forward-looking statements represent our expectations
or beliefs concerning future events, including the following: our ability to
become profitable, market acceptance of the Duett sealing device, our dependence
on the Duett sealing device, our ability to remain competitive and achieve
future growth, any statement regarding the future of the vascular sealing device
industry or our business plans and strategies. We caution you that any forward-
looking statements made by us in this Form 10-Q or in other announcements made
by us are further
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qualified by important factors that could cause actual results to differ
materially from those in the forward-looking statements, including, without
limitation, the factors set forth below.
Because we only began product development in February 1997, we have a limited
operating history upon which to evaluate our potential for future success
We began product development in February 1997 and began to generate
international sales in February 1998. Accordingly, we have only three years of
operating history upon which you can evaluate our business and prospects. You
must consider the risks and uncertainties frequently encountered by early stage,
single-product medical device companies like ours in a new and evolving market,
such as the vascular sealing device market. If we are unsuccessful in addressing
these risks and uncertainties, our business will be seriously harmed.
We have been named as the defendant in two patent infringement lawsuits and may
face additional intellectual property infringement claims in the future which
could prevent us from manufacturing and selling our product or result in our
incurring substantial costs and liabilities
An adverse determination in any intellectual property litigation or
interference proceedings could prohibit us from selling our product, subject us
to significant liabilities to third parties or require us to seek licenses from
third parties. The costs associated with these license arrangements may be
substantial and could include ongoing royalties. Furthermore, the necessary
licenses may not be available to us on satisfactory terms, if at all. Adverse
determinations in a judicial or administrative proceeding or failure to obtain
necessary licenses could prevent us from manufacturing and selling our product.
On July 23, 1999, we were named as the defendant in a patent infringement
lawsuit brought by Datascope Corp. in the United States District Court for the
District of Minnesota. The complaint requested a judgment that our Duett sealing
device infringes and, following FDA approval, will infringe a United States
patent held by Datascope and asks for relief in the form of an injunction that
would prevent us from selling our product in the United States as well as an
award of attorneys' fees, costs and disbursements. On March 15, 2000, the court
granted summary judgment dismissing all of Datascope's claims, subject to the
right of Datascope to recommence the litigation after our receipt of FDA
approval of our Duett sealing device. On July 12, 2000, after our receipt of FDA
approval, Datascope recommenced this litigation, alleging that the Duett sealing
device infringes a United States patent held by Datascope and requesting relief
in the form of an injunction that would prevent us from selling our product in
the United States, damages caused by our alleged infringement, and other costs,
disbursements and attorneys' fees. It is not possible to predict the timing or
outcome of this lawsuit, including whether we will be prohibited from selling
our Duett sealing device in the United States or internationally, or to estimate
the amount or range of potential loss, if any.
On September 22, 1999, we received a letter from the Daig division of St. Jude
Medical, Inc. claiming that the manufacture, use, marketing and sale of our
Duett sealing device infringes upon certain United States patents licensed by
Daig. The letter referenced a prior letter dated August 18, 1998 from us to the
prior licensee of those patents in which we made a proposal intended to avoid
the anticipated litigation over those patents. The proposed license was
rejected. On July 3, 2000, we were named as the defendant in a patent
infringement lawsuit brought by St. Jude Medical and Daig Corporation in the
United States District Court for the District of Minnesota. The complaint
requests a judgment that our Duett sealing device infringes a series of four
patents held by St. Jude Medical and asks for relief in the form of an
injunction that would prevent us from selling our product in the United States,
damages caused by the manufacture and sale of our product, and other costs,
disbursements and attorneys' fees. It
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is not possible to predict the timing or outcome of this lawsuit, including
whether we will be prohibited from selling our Duett sealing device in the
United States or internationally, or to estimate the amount or range of
potential loss, if any.
The interventional cardiology industry is characterized by numerous patent
filings and frequent and substantial intellectual property litigation. Companies
in the interventional cardiology industry in general, and in vascular sealing in
particular, have employed intellectual property litigation in an attempt to gain
a competitive advantage. We are aware of many United States patents issued to
other companies in the vascular sealing field which describe vascular sealing
devices. Each of the three vascular sealing products with which our Duett
sealing device competes has been subject to infringement litigation. We may
become the subject of additional intellectual property claims in the future
related to our Duett sealing device. Intellectual property litigation in recent
years has proven to be very complex, and the outcome of such litigation is
difficult to predict.
Our defense of the Datascope claim, the St. Jude Medical claim and any other
intellectual property claims filed in the future, regardless of the merits of
the complaint, could divert the attention of our technical and management
personnel away from the development and marketing of the Duett sealing device
for significant periods of time. The costs incurred to defend the Datascope
claim, the St. Jude Medical claim and other future claims could be substantial
and seriously harm us, even if our defense is ultimately successful.
We will not be successful if the vascular sealing device market does not adopt
our new sealing methodology
We have sold only a limited number of our Duett sealing devices to date and
have only very recently commenced sales of our product in the United States,
which we believe represents the largest market for vascular sealing devices. Our
success will depend on the medical community's acceptance of our Duett sealing
device. We cannot predict how quickly, if at all, the medical community will
accept our Duett sealing device, or, if accepted, the extent of its use. Our
potential customers must:
. believe that our device offers benefits compared to the methodologies
and/or devices that they are currently using to seal vascular punctures;
. believe that our device is worth the price that they will be asked to pay;
and
. be willing to commit the time and resources required to change their
current methodology.
If we encounter difficulties introducing our Duett sealing device into the
United States market or expanding our presence in markets outside the United
States, our business will be seriously harmed.
We currently rely on the Duett sealing device as our sole source of revenue
We have developed only one product which is being sold in a limited number of
international markets and have only very recently received FDA approval for sale
in the United States. Even if we were to develop additional products, FDA
approval would be required in order to sell them in the United States.
Preparation of the requisite materials to seek FDA approval and the approval
process itself require a substantial amount of time and money. Therefore, we do
not expect to be in a position to sell additional products in the foreseeable
future. As a result, our success is solely dependent on the success of our Duett
sealing device. If our Duett sealing device is not successful, our business will
be seriously harmed.
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We have incurred losses and we may not be profitable in the future
Since we commenced operations in February 1997, we have incurred net losses
from costs relating to the development and commercialization of our Duett
sealing device. At June 30, 2000, we had an accumulated deficit of $19.4
million. We expect to continue to significantly increase our sales and
marketing, research and development and general and administrative expenses. In
particular, we are in the process of hiring, training and deploying a direct
sales force to sell our Duett sealing device in the United States. Because of
our plans to invest heavily in sales and marketing, hire additional employees
and expand our commercialization, we expect to incur significant net losses
through at least December 31, 2000. Our business strategies may not be
successful and we may not be profitable in any future period. If we do become
profitable, we cannot be certain that we can sustain or increase profitability
on a quarterly or annual basis.
Our future operating results are difficult to predict and may vary significantly
from quarter to quarter, which may adversely affect the price of our common
stock
The very recent FDA approval of our Duett sealing device and history of losses
make prediction of future operating results difficult. You should not rely on
our past revenue growth as any indication of future growth rates or operating
results. The price of our common stock will likely fall in the event that our
operating results do not meet the expectations of analysts and investors.
Comparisons of our quarterly operating results are an unreliable indication of
our future performance because they are likely to vary significantly based on
many factors, including:
. the results of the introduction of our Duett sealing device into the United
States market;
. the effect of intellectual property disputes;
. the demand for and acceptance of our Duett sealing device;
. the success of our competition and the introduction of alternative means
for vascular sealing;
. our ability to command favorable pricing for our Duett sealing device;
. the growth of the market for vascular sealing devices;
. the expansion and rate of success of our direct sales force in the United
States and our independent distributors internationally;
. actions relating to ongoing FDA compliance;
. the size and timing of orders from independent distributors or customers;
. the attraction and retention of key personnel, particularly in sales and
marketing, regulatory, manufacturing and research and development;
. unanticipated delays or an inability to control costs with respect to our
Duett sealing device;
. our ability to introduce new products and enhancements in a timely manner;
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. general economic conditions as well as those specific to our customers and
markets; and
. seasonal fluctuations in revenue due to the elective nature of some
procedures.
Our direct sales efforts may not be successful because we have no operating
history with a direct sales force
Because we have only very recently received regulatory approval to sell our
Duett sealing device in the United States, we have no operating history with a
direct sales force. We are in the process of hiring a direct sales force,
including clinical specialists to perform physician training, to commercialize
our Duett sealing device in the United States. We currently anticipate that
sales and marketing expenses will increase for the foreseeable future as we
hire, train and deploy a direct sales force in the United States. We believe
that our new salespeople and clinical specialists will require approximately
three months from their hiring date to become productive selling and training
physicians to use our Duett sealing device. Furthermore, we believe that there
is significant competition for direct sales personnel and clinical specialists
with the advanced sales skills and technical knowledge we require. We may not be
able to obtain, train and retain direct sales personnel and the future sales
efforts of our direct sales force may not be successful.
We may face product liability claims that could result in costly litigation and
significant liabilities
The manufacture and sale of medical products entail significant risk of
product liability claims. The medical device industry in general has been
subject to significant medical malpractice litigation. Any product liability
claims, with or without merit, could result in costly litigation, reduced sales,
cause us to incur significant liabilities and divert our management's time,
attention and resources. Because of our limited operating history and lack of
experience with these claims, we cannot be sure that our product liability
insurance coverage is adequate or that it will continue to be available to us on
acceptable terms, if at all.
The market for vascular sealing devices is highly competitive and will likely
become more competitive, and our competitors may be able to respond more quickly
to new or emerging technologies and changes in customer requirements that may
render our Duett sealing device obsolete
The existing market for vascular sealing devices is intensely competitive. We
expect competition to increase further as additional companies begin to enter
this market and/or modify their existing products to compete directly with ours.
Our primary competitors are Abbott Laboratories (through its subsidiary
Perclose, Inc.), Datascope Corp. and St. Jude Medical, Inc., which sells a
product developed by Kensey Nash Corporation. These companies have:
. better name recognition;
. broader product lines;
. greater sales, marketing and distribution capabilities;
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. significantly greater financial resources;
. larger research and development staffs and facilities; and
. existing relationships with some of our potential customers.
We may not be able to effectively compete with these companies. In addition,
broad product lines may allow our competitors to negotiate exclusive, long-term
supply contracts and offer comprehensive pricing for their products. Broader
product lines may also provide our competitors with a significant advantage in
marketing competing products to group purchasing organizations and other managed
care organizations that are increasingly seeking to reduce costs through
centralized purchasing. Greater financial resources and product development
capabilities may allow our competitors to respond more quickly to new or
emerging technologies and changes in customer requirements that may render our
Duett sealing device obsolete.
We currently depend on the international marketing and sales efforts of a
limited number of independent distributors
Our Duett sealing device is sold internationally through independent
distributors in Germany, Norway, Italy, Austria, the United Kingdom, Denmark,
Switzerland, Finland, Sweden, Greece, Belgium, Spain, the Netherlands, Taiwan
and Hong Kong. Our international sales are largely dependent on the marketing
efforts of, and sales by, these distributors. Sales through distributors are
subject to several risks, including the risk of financial instability of
distributors and the risk that distributors will not effectively promote our
Duett sealing device. Loss or termination of these distribution relationships
could seriously harm our international sales efforts and could result in our
repurchasing unsold inventory from former distributors by virtue of local laws
applicable to distribution relationships, provisions of distribution agreements
or negotiated settlements entered into with our distributors. Sales to our
German, Norwegian, Italian and Austrian distributors accounted for approximately
30%, 26%, 17% and 9% of net sales for the six months ended June 30, 2000.
Our international sales are subject to a number of risks that could seriously
harm our ability to successfully commercialize our Duett sealing device in any
international market
Substantially all of our sales to date have been outside the United States.
Our international sales are subject to several risks, including:
. the impact of recessions in economies outside the United States;
. greater difficulty in collecting accounts receivable and longer collection
periods;
. unexpected changes in regulatory requirements, tariffs or other trade
barriers;
. weaker intellectual property rights protection in some countries;
. potentially adverse tax consequences; and
. political and economic instability.
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The occurrence of any of these events could seriously harm our future
international sales and our ability to successfully commercialize our Duett
sealing device or any future product in any international market.
We have limited manufacturing experience and may encounter difficulties in
expanding our manufacturing operations which could seriously harm our business
We have limited experience in manufacturing our Duett sealing device. Until
very recently, we have manufactured the Duett sealing device in limited
quantities for international sales and clinical studies in the United States. We
do not have experience in manufacturing our Duett sealing device in substantial
commercial quantities. We believe our current facilities are adequate for our
projected production of our Duett sealing device for the next year, but future
facility requirements will depend largely on future sales of our product in the
United States. We may encounter unforeseen difficulties in expanding our
production of our Duett sealing device and new products, including problems
involving production yields, quality control and assurance, component supply and
shortages of qualified personnel, compliance with FDA regulations and
requirements regarding good manufacturing practices, and the need for further
regulatory approval of new manufacturing processes. Difficulties encountered by
us in expanding our manufacturing capabilities could seriously harm our
business.
Our business and results of operations may be seriously harmed by changes in
third-party reimbursement policies
We could be seriously harmed by changes in reimbursement policies of
governmental or private healthcare payors, particularly to the extent any
changes affect reimbursement for catheterization procedures in which our Duett
sealing device is used. Failure by physicians, hospitals and other users of our
Duett sealing device to obtain sufficient reimbursement from healthcare payors
for procedures in which our Duett sealing device is used or adverse changes in
governmental and private third-party payors' policies toward reimbursement for
such procedures would seriously harm our business.
In the United States, healthcare providers, including hospitals and clinics
that purchase medical devices such as our Duett sealing device, generally rely
on third-party payors, principally federal Medicare, state Medicaid and private
health insurance plans, to reimburse all or part of the cost of catheterization
procedures. We believe that in a prospective payment system, such as the system
currently used by Medicare, and in many managed care systems used by private
healthcare payors, the cost of the Duett sealing device will be incorporated
into the overall cost of the procedure and that there will be no separate,
additional reimbursement for our product. The Health Care Financing
Administration is in the process of implementing a new Medicare prospective
payment system for hospital outpatient services. It is uncertain what impact
this new system may have on sales of our product.
In international markets, acceptance of our Duett sealing device is dependent
in part upon the availability of reimbursement within prevailing healthcare
payment systems. However, we are unaware of any hospitals that receive specific,
cost-based, direct reimbursement for the use of our Duett sealing device.
Reimbursement and healthcare payment systems in international markets vary
significantly by country. Our failure to receive international reimbursement
approvals could have a negative impact on market acceptance of our Duett sealing
device in the markets in which these approvals are sought.
Our Duett sealing device and our manufacturing activities are subject to
extensive governmental regulation that could prevent us from selling our Duett
sealing device in the United States or introducing new and improved products
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Our Duett sealing device and our manufacturing activities are subject to
extensive regulation by a number of governmental agencies, including the FDA and
comparable international agencies. We are required to:
. obtain the approval of the FDA and international agencies before we can
market and sell our products;
. satisfy these agencies' content requirements for all of our labeling, sales
and promotional materials; and
. undergo rigorous inspections by these agencies.
Compliance with the regulations of these agencies may delay or prevent us from
introducing any new model of our Duett sealing device or other products.
Furthermore, we may be subject to sanctions, including temporary or permanent
suspension of operations, product recalls and marketing restrictions if we fail
to comply with the laws and regulations pertaining to our business.
We are also required to demonstrate compliance with the FDA's quality system
regulations. The FDA enforces its quality system regulations through pre-
approval and periodic post-approval inspections. These regulations relate to
product testing, vendor qualification, design control and quality assurance, as
well as the maintenance of records and documentation. If we are unable to
conform to these regulations, the FDA may take actions which could seriously
harm our business.
We are currently conducting two post approval studies of our Duett sealing
device as required by the FDA. It is likely that we will conduct further studies
on the use of our Duett sealing device for the foreseeable future. The FDA and
international regulatory agencies may restrict or withdraw their approval of our
Duett sealing device if additional information becomes available to support this
action through these studies or otherwise.
The loss of, or interruption of supply from, key vendors, including single
source suppliers, could limit our ability to manufacture our Duett sealing
device
We purchase components used in our Duett sealing device from various suppliers
and rely on single sources for the collagen and thrombin components of our Duett
sealing device procoagulant. There are currently no FDA-approved alternative
suppliers of thrombin and very few FDA-approved alternative suppliers of
collagen. Because it requires FDA approval, establishing additional or
replacement suppliers for thrombin would require a lead-time of at least two
years and would involve significant additional costs. Any supply interruption
from key vendors or failure by us to engage alternative vendors may limit our
ability to manufacture our Duett sealing device and could therefore seriously
harm our business.
Our failure to expand our management systems and controls to support anticipated
growth could seriously harm our business
Our operations are growing rapidly and we expect this expansion to continue as
we execute our business strategy. Our total number of employees grew from 48 on
June 30, 1999 to 101 on June 30, 2000. We anticipate further increases in the
number of our employees. Sustaining our growth has placed significant demands on
management and our administrative, operational, personnel and financial
resources. Accordingly, our future operating results will depend on the ability
of our officers and other
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key employees to continue to implement and improve our operational, client
support and financial control systems, and effectively expand, train and manage
our employee base. We may not be able to manage our growth successfully and
inability to sustain or manage our growth could seriously harm our business.
Concentration of ownership of our company may give some shareholders substantial
influence and may prevent or delay a change in control of our company
Our executive officers and directors, together with their affiliates, in the
aggregate, beneficially own approximately 5,789,662 shares, or 45.4%, of our
total outstanding common stock as of July 31, 2000. These shareholders may be
able to exercise substantial influence over all matters requiring shareholder
approval, including the election of directors and approval of significant
corporate transactions. This concentration of ownership may also have the effect
of delaying or preventing a change in control of our company.
Our articles of incorporation and Minnesota law may discourage an acquisition of
our company
Provisions of our articles of incorporation and Minnesota law could make it
more difficult for a third party to acquire us, even if doing so would be
beneficial to our shareholders.
The price of our common stock could be highly volatile due to a number of
factors
The trading price of our common stock may fluctuate widely as a result of a
number of factors, including:
. performance of our Duett sealing device in the United States market;
. actions taken by the FDA concerning our products;
. market perception and customer acceptance of vascular sealing devices;
. increased competition;
. litigation concerning intellectual property rights;
. the loss of significant orders;
. general conditions in the medical device industry; and
. changes in earnings estimates by analysts.
In addition, the stock market for medical device companies has experienced
extreme price and volume fluctuations, which have often been unrelated to the
operating performance of the companies experiencing these fluctuations.
Future sales of our common stock in the public market could cause our stock
price to fall
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If our shareholders sell substantial amounts of our common stock in the public
market, the market price of our common stock could fall. As of July 31, 2000, we
have 12,562,528 outstanding shares of common stock. Other than the 3,802,250
shares which are freely tradeable, an additional 95,160 shares will be freely
tradeable on October 17, 2000 and 8,665,118 shares will become freely tradeable
at varying dates after January 14, 2001 upon the expiration of lock-up
agreements between our existing shareholders and the underwriters.
If holders of our common stock that have registration rights require us to
register a large number of their shares for sale into the public market, the
market price of our common stock and our ability to raise needed capital could
be significantly harmed
On January 15, 2001, the holders of 3,777,777 shares of our common stock,
which represent 30% of our outstanding common stock as of July 31, 2000, and the
holders of warrants to purchase 168,000 shares of our common stock will be
entitled to have the resale of their shares registered under the Securities Act
of 1933. If these holders cause a large number of shares to be registered and
sold in the public market, such sales could seriously harm the market price for
our common stock. In addition, if we include in a company-initiated registration
shares held by these holders pursuant to the exercise of their registration
rights, such sales may have a negative impact on our ability to raise needed
capital.
Item 3. Quantitative and Qualitative Disclosure About Market Risks
Financial instruments that potentially subject us to concentrations of credit
risk consist primarily of cash and cash equivalents and accounts receivables. We
maintain our accounts for cash and cash equivalents principally at one major
bank in the United States. We have a formal written investment policy that
restricts the placement of investments to issuers evaluated as creditworthy. We
have not experienced any losses on our deposits of our cash and cash
equivalents.
With respect to accounts receivable, we perform credit evaluations of our
customers and do not require collateral. There have been no material losses on
customer receivables.
We operate in a single industry segment and sell our product to distributors
who, in turn, sell to medical clinics. We sell our product in foreign countries
through independent distributors denominated in United States dollars. Loss,
termination or ineffectiveness of distributors to effectively promote our
product would have a material adverse effect on our financial condition and
results of operations.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
On July 23, 1999, we were named as the defendant in a patent infringement
lawsuit brought by Datascope Corp. in the United States District Court for the
District of Minnesota. The complaint requested a judgment that our Duett sealing
device infringes and, following FDA approval, will infringe a United States
patent held by Datascope and asks for relief in the form of an injunction that
would prevent us from selling our product in the United States as well as an
award of attorneys' fees, costs and disbursements. On March 15, 2000, the court
granted summary judgment dismissing all of Datascope's claims, subject to the
right of Datascope to recommence the litigation after our receipt of FDA
approval of our Duett sealing device. On July 12, 2000, after our receipt of FDA
approval, Datascope
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recommenced this litigation, alleging that the Duett sealing device infringes a
United States patent held by Datascope and requesting relief in the form of an
injunction that would prevent us from selling our product in the United States,
damages caused by our alleged infringement, and other costs, disbursements and
attorneys' fees. It is not possible to predict the timing or outcome of this
lawsuit, including whether we will be prohibited from selling our Duett sealing
device in the United States or internationally, or to estimate the amount or
range of potential loss, if any.
On September 22, 1999, we received a letter from the Daig division of St.
Jude Medical, Inc. claiming that the manufacture, use, marketing and sale of our
Duett sealing device infringes upon certain United States patents licensed by
Daig. The letter referenced a prior letter dated August 18, 1998 from us to the
prior licensee of those patents in which we made a proposal intended to avoid
the anticipated litigation over those patents. The proposed license was
rejected. On July 3, 2000, we were named as the defendant in a patent
infringement lawsuit brought by St. Jude Medical and Daig Corporation in the
United States District Court for the District of Minnesota. The complaint
requests a judgment that our Duett sealing device infringes a series of four
patents held by St. Jude Medical and asks for relief in the form of an
injunction that would prevent us from selling our product in the United States,
damages caused by the manufacture and sale of our product, and other costs,
disbursements and attorneys' fees. It is not possible to predict the timing or
outcome of this lawsuit, including whether we will be prohibited from selling
our Duett sealing device in the United States or internationally, or to estimate
the amount or range of potential loss, if any.
Item 2. Changes in Securities and Use of Proceeds
(a) Not applicable
(b) Not applicable
(c) Grants and Exercises of Stock Options
During the three-month period ended June 30, 2000, we granted stock
options to purchase an aggregate of 22,500 shares of our common stock
at an exercise price of $10.00 per share to employees and consultants
pursuant to our stock option and stock award plan (the "Stock Option
Plan"). During the three-month period ended June 30, 2000, we issued
and sold an aggregate of 13,000 shares of our common stock to
employees, former employees and consultants for aggregate
consideration of $32,800 pursuant to exercises of options under our
Stock Option Plan. These sales were made in reliance upon an exemption
from the registration provisions of the Securities Act set forth in
Rule 701 of the Securities Act.
(d) Initial Public Offering
On July 25, 2000, we sold 3,500,000 shares of our common stock, at an
initial public offering price of $12.00 per share, pursuant to a
Registration Statement on Form S-1 (Registration No. 333-84089), which
was declared effective by the Securities and Exchange Commission on
July 19, 2000. The managing underwriters of our initial public
offering were Salomon Smith Barney Inc., Stephens Inc. and William
Blair & Company, L.L.C. The underwriters have a 30-day option to
purchase an additional 525,000 shares at $12.00 per share expiring on
August 19, 2000. The aggregate gross proceeds raised in the offering
were
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approximately $42.0 million. Our net proceeds from the offering were
approximately $38.7 million.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
Item 5. Other Information
None.
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits:
27.1 -- Financial Data Schedule for the three months ended June 30,
2000.
27.2 -- Financial Data Schedule for the six months ended June 30,
2000.
(b) Reports on Form 8-K:
The Company did not file any Current Report on Form 8-K during the
quarter ended June 30, 2000.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
VASCULAR SOLUTIONS, INC.
Date: August 3, 2000 By: /s/ Jerry Johnson
---------------------------
Jerry S. Johnson
Chief Financial Officer
(Duly authorized officer and
principal financial and
accounting officer)
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EXHIBIT INDEX
-------------
27.1 -- Financial Data Schedule for the three months ended June 30, 2000.
27.2 -- Financial Data Schedule for the six months ended June 30, 2000.
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